Quality Engineer - Molding / Medical Devices

Job Title: Quality Engineer – Molding / Medical Devices

Location: Libertyville, IL

Work Arrangement: Onsite

Experience: 5–7 Years

Job Overview

We are seeking an experienced Quality Engineer with strong expertise in molding processes, quality engineering, and medical device manufacturing . The ideal candidate will have hands-on experience with molding operations, quality testing, PFMEA, Design of Experiments (DOE), process characterization, continuous improvement, and problem solving.

Experience working within a highly regulated medical device manufacturing environment and familiarity with ISO 13485 quality standards is highly preferred.

Key Responsibilities

• Support setup and operation of molding processing equipment.
• Perform and support quality testing of molded products.
• Apply PFMEA methodologies to molding and manufacturing processes.
• Conduct Design of Experiments (DOE) and process characterization activities.
• Support process validation, test runs, and production trials.
• Analyze quality and process data to identify yield and process-related issues.
• Prepare quality records, reports, charts, and graphs for technical review and presentations.
• Drive continuous improvement, root-cause analysis, and corrective problem-solving initiatives.
• Support yield improvement and process optimization activities.
• Provide technical assistance to process development and manufacturing engineering teams.
• Support new product and process development activities.
• Work with cross-functional teams to resolve quality and manufacturing issues.
• Interface with customers and support customer quality-related activities when required.
• Ensure manufacturing and quality activities align with applicable medical-device quality standards.

Required Skills

• 5–7 years of relevant Quality Engineering experience.
• Hands-on experience with molding/injection molding processes .
• Experience with molded/plastic components and manufacturing operations.
• Strong understanding of PFMEA .
• Experience with Design of Experiments (DOE) .
• Process characterization and process improvement experience.
• Quality testing and inspection experience.
• Root-cause analysis and structured problem-solving skills.
• Experience with production yield improvement.
• Experience in medical device manufacturing or another highly regulated manufacturing environment.
• Knowledge of ISO 13485 and medical-device quality systems.
• Ability to analyze quality/process data and prepare technical reports, charts, and graphs.
• Strong written and verbal communication skills.
• Ability to work effectively with manufacturing, process development, engineering, and quality teams.

Preferred Experience

• FDA-regulated manufacturing environments.
• Process validation and production qualification.
• New product introduction (NPI).
• Process development support.
• Customer-facing quality engineering.
• Quality documentation and technical reporting.
• High-volume manufacturing environments.
• Experience with continuous improvement methodologies.

Education

Bachelor's degree in Engineering or a related discipline such as:

• Mechanical Engineering
• Manufacturing Engineering
• Industrial Engineering
• Plastics/Polymer Engineering
• Quality Engineering
• Related Engineering field